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ENGLISH 5401000301 EN Rev. B
IFU FOR INSTRUMENTS AND CASES UKBEN54010003011
FOR THE ATTENTION OF THE OPERATING SURGEON, HEALTHCARE PROFESSIONALS, CENTRAL STERILE SERVICES DEPARTMENT (CSSD) PERSONNEL For additional information please see: http://labeling.zimmerbiomet.com/ SURGICAL INSTRUMENTS For detailed information concerning the identification of the product (such as device description, catalogue number and associated system), please refer to the labelling on the package and/or marking on the device. Important information for the operating surgeon Before using an instrument placed on the market by Zimmer Biomet, the operating surgeon, healthcare professionals and central sterile services department (CSSD) personnel should study carefully the following recommendations, warnings and instructions, as well as the available instrument-specific information (e.g. product literature, surgical technique, Reusable Instrument Lifespan Manual 1219 and Instrument Assembly and Disassembly Manual 1258 or product-specific Assembly and Disassembly Manual where applicable) from your Zimmer Biomet sales representative or at http://labeling.zimmerbiomet.com. Zimmer Biomet is not liable for complications that may arise from use of the instruments in circumstances outside the control of Zimmer or Biomet including, but not limited to, deviations from the instruments’ indicated uses or surgical technique. DESCRIPTION These instructions for use (IFU) provide information on the care, cleaning, disinfection, maintenance and sterilization of manual surgical instruments. Biomet surgical instruments and instrument cases are generally composed of aluminium, stainless steel, and/or polymeric materials. The cases may be multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays. The instrument cases are perforated to allow steam to penetrate these various materials and components. The instrument cases will allow for sterilization of the contents to occur in a steam sterilizer utilizing a cycle that has been validated by the user for the equipment and procedures employed at the user’s facility. Instrument cases do not provide a sterile barrier and must be used in conjunction with a sterilization wrap or rigid container to maintain sterility. INTENDED PURPOSE Biomet surgical instruments are designed for Biomet® implant systems and intended to be used by orthopaedic surgeons to facilitate the implantation or explantation of specific implants described in the product-specific surgical technique or surgical approach. The use of the identified instrumentation in accordance with its applicable surgical technique and IFU is essential to achieve the intended placement of the implant as described in the relevant surgical technique. The use of incompatible instruments (e.g. from another system) may lead to unpredictable short- and long- term clinical consequences. The incorrect use of the subject instrumentation may also lead to short- and long term clinical consequences. Sterilization case components are intended to facilitate the organization, identification, storage, transportation, cleaning, and sterilization reprocessing of instruments and provisionals. General surgical instruments are available to facilitate surgical procedures unrelated to a specific implant system or related to a surgical approach. The patient target population can be found in the specific implant instructions for use.
Change Control No: 232263 Revision B Date: August 2021 © Biomet
BIOMET UK LIMITED WATERTON INDUSTRIAL ESTATE BRIDGEND, CF31 3XA UNITED KINGDOM TEL: + 44 (0) 1656655221 FAX: + 44 (0) 1656645454 www.zimmerbiomet.com For individual CE mark of instruments, refer to the product label INTENDED USERS Operating surgeon, healthcare professionals and central sterile services department (CSSD) personnel. Table 1. Materials Scientific notation CF-PEEK PEEK SST or Stainless Steel Co-Cr-Mo PPSU Ti-6Al-4V POM/C Silicone PPHS PTFE
Material Description Carbon fibre – Poly ether ether ketone Polyether ether ketone Stainless steel Cobalt-chromium-molybdenum alloy Polyphenylsulfone Titanium-6aluminium-4vanadium alloy Polyacetal copolymer Silicone Heat-stabilized polypropylene Teflon / Polytetrafluoroethylene
INDICATIONS, CONTRAINDICATIONS AND PATIENT SELECTION FACTORS Refer to the implant-specific IFU for information on the intended purpose, indications and contraindications of the implant. WARNINGS, PRECAUTIONS AND RESIDUAL RISKS Correct use and handling of instruments is extremely important. Do not modify instruments. Do not notch or bend instruments. Notches, scratches or other damage and/or wear in the instrument occurring during surgery may contribute to breakage and potential adverse effects on users or patients. 1. Do not reshape or bend instruments in any way. Do not use an instrument that has become bent out of its original shape as this will affect the performance of the instrument. See also the Reusable Instrument Lifespan Manual 1219 for determining end of life by wear and damage due to use. Bent instruments should be disposed of. 2. The Surgeon is to be thoroughly familiar with the implants, instruments, surgical technique and surgical procedure prior to performing surgery. For Instruments intended to be connected to a power tool refer to the applicable surgical technique for information on the connection to the power tool. Visit the company website (see front page) or contact your local Zimmer Biomet representative to obtain the latest surgical technique. 3. Surgical instruments should only be used for their intended purpose. 4. Only devices manufactured and/or distributed by Biomet should be included in Biomet instrument trays and cases. These validated reprocessing instructions are not applicable to Biomet trays and cases that include devices that are not manufactured and/or distributed by Biomet. 5. The use of instruments and provisionals with devices not designed to be used with during the surgical procedure can result in inaccurate fit, in correct sizing, excessive wear and device failure. Refer to the product-specific surgical technique or associated surgical approach for accepted combinations. General instruments such as hammer can be used safely across systems and do not raise compatibility concerns due to their generic intended use or function. 6. Intraoperative fracture or breaking of instruments has been reported for instruments. 7. Biomet recommends that all instruments be regularly inspected for wear and disfigurement prior to use See also the reusable instruments Lifespan Manual 1219 for determining end of life by wear and damage due to use. All trial, packaging, and instrument components must be removed prior to closing the surgical site. Do not implant. 8. Surgical instruments are subject to wear with normal usage. Instruments with cutting functions or points may become dull with normal use and no longer perform as intended. Inspect prior to use to verify the cutting ability and sharpness of edges. See also the reusable instruments Lifespan Manual 1219 for determining end of life by wear and damage due to use. 9. The use of instruments overtime may lead to wear and particle release, which could have clinical implications and potentially lead to adverse events. 10. Instruments that have experienced extensive use or excessive force are susceptible to fracture.
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11. Polymer provisionals may show eventual surface degradation from the heat and chemicals used in hospital cleaning and steam sterilization. Replace the provisional when degradation makes cleaning difficult or if the surface becomes chalky. 12. Universal precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated medical devices. Caution should be exercised when handling devices with sharp points or cutting edges. 13. The patient is to be warned by his/her physician of all surgical risks and made aware of possible adverse effects in advance of surgery. The patient should also be informed about any product related risks identified in the relevant instrumentation and implant system IFU. 14. Unless otherwise indicated, instruments are NOT STERILE and must be thoroughly cleaned and sterilized prior to use as per instructions provided in this IFU. 15. Instruments must be thoroughly cleaned prior to sterilization. Instruments that are not clean may not be effectively sterilized. See also Instruments Assembly Disassembly Manual 1258 or product-specific Assembly Disassembly Manual where applicable. 16. Automated cleaning using a washer/disinfector alone may not be effective for complex instruments with lumens, cannulations, blind holes, mated surfaces and other features that may need to be disassembled before cleaning. Therefore, manual cleaning may also be required. See also Instruments Assembly Disassembly Manual 1258 or product-specific Assembly Disassembly Manual, where applicable, for disassembly instructions prior to cleaning/sterilization. 17. Do not clean soiled instruments while in polymer or metal trays. 18. Metal instruments or fragments can be located by radiography or fluoroscopy. Non-metal instruments or fragments may not be located by radiography or fluoroscopy, and should be accounted for at the end of the surgical procedure. 19. Any decision not to remove broken or fragmented instruments, or a broken drill or drill fragments, is at the surgeon’s discretion and must take into account the associated risk. 20. If corrosive media such as silver nitrate, iodine preparations, albotyl and mercury compounds are used during the operation, all residues of these substances must be removed from the instruments immediately. 21. The presence of potential carcinogenic, mutagenic or toxic to reproduction (CMR) substances and/or substances with endocrine disrupting properties defined as CMR 1B substances in a concentration above 0.1% weight by weight in the product is indicated by the symbol on the product label followed by the respective substance identifier. • Cobalt; CAS No.: 7440-48-4 For further details, please review: https://echa.europa.eu/home. There are isolated case studies in which patients were diagnosed with cancer while having a device manufactured from cobalt alloys in place that hypothesized at a causal nexus between the device and the diagnosis. However, current scientific evidence supports that the incidence of developing cancer or suffering from adverse reproductive effects for patients with a device manufactured from cobalt alloys or stainless steel alloys containing cobalt is comparable to the respective incidence for the general population. 22. Patients/users hypersensitive to any of the instruments material (e.g. cobalt, chromium, nickel) may suffer an allergic reaction. The duration of the contact between instruments and patient/users is transient. If you have any concerns for potential allergic reactions, please contact your Zimmer Biomet sales representative. RESPONSIBILITIES OF THE USER A. Cleaning/Disinfection The health care facility is responsible for ensuring that conditions essential to safe handling and cleaning/disinfection can be achieved. ANSI/AAMI/ ISO 17664 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices and ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provide guidelines for design and personnel considerations, immediate handling of contaminated items and transportation, decontamination processes, servicing, repair, and process performance. Universal Precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated medical devices. Care should be taken to avoid penetrating or cutting injuries. Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated materials, devices and equipment. PPE includes gown, mask, goggles or face shield, gloves and shoe covers. Cleaning agents with low foaming surfactants should be used during manual cleaning procedures to ensure that instruments are visible in the cleaning solution. Manual scrubbing with brushes should always be performed with the instrument below the surface of the cleaning solution to prevent generation of aerosols and splashing, which may spread contaminants. Cleaning agents must be completely rinsed from device surfaces to prevent accumulation of detergent residue. See Assembly and Disassembly Manual 1258 or product-specific Assembly and Disassembly Manual, where applicable, for detailed guidelines related to instrument assembly and disassembly, available from your Zimmer Biomet sales representative or at http://labeling.zimmerbiomet.com.
B. Sterilization The health care facility is responsible for ensuring that any packaging method or material, including a reusable rigid container system, is suitable for use in sterilization processing and sterility maintenance in a particular health care facility. ANSI/AAMI/ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices and ANSI/ AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provide guidelines for preparation and assembly, sterilizer loading and unloading, matching the container system to the appropriate sterilization cycle, quality assurance, sterile storage, transport, and aseptic use. USE AND CARE OF SURGICAL INSTRUMENTS/CASES Surgical instruments and instrument cases are susceptible to damage for a variety of reasons, including the following: prolonged use; misuse; rough or improper handling. Care must be taken to avoid compromising the performance of the surgical instruments and instrument cases. To minimize damage and risk of injury and potential adverse effects on users and patients, the following should be reviewed: • See Reusable Instrument Lifespan Manual 1219 for guidance on determining reusable instrument suitability for use, available from your Zimmer Biomet sales representative or at http://labeling.zimmerbiomet.com. • Instruments delivered in a transportation package shall be placed in the specific tray before initial processing in the hospital. • Inspect the instrument case and instruments for damage upon receipt, after each use and cleaning and prior to use. Instruments in need of repair should be set aside for repair service or returned to Zimmer Biomet. Instruments returned to Zimmer Biomet or its distributors should be cleaned and sterilized prior to shipment. ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provides guidelines for return, or contact Zimmer Biomet or your distributor for further instructions. • Only use an instrument for its intended purpose. • When handling sharp instruments, use extreme caution to avoid injury. Consult an infection control practitioner to develop and verify safety procedures appropriate for all levels of direct instrument contact and disposal. In the event of an alleged product failure, it is important to have the instrumentation returned to Zimmer Biomet for investigation. • Alkaline detergents with pH ≤ 12 may be used to clean stainless steel and polymer instruments; however, it is critical that alkaline cleaning agents are thoroughly neutralized and rinsed off devices. The use of alkaline cleaning agents might be corrosive to the surface of aluminium and titanium instruments. Drill bits, reamers, rasps and other cutting devices should be carefully inspected after processing with alkaline detergents to ensure that cutting edges are fit for use. • Metal brushes or scouring pads must not be used during manual cleaning procedures. These materials will damage the surface and finish of instruments. Soft-bristled, nylon brushes and pipe cleaners should be used. • Do not stack instruments or place heavy instruments on top of delicate devices. • Saline and cleaning/disinfection agents containing aldehyde, mercury, active chlorine, chloride, bromine, bromide, iodine or iodide are corrosive and should not be used. Instruments must not be placed or soaked in Ringer’s solution. • Descaling agents that include morpholine should not be used in steam sterilizers. These agents leave residues that can damage polymer instruments over time. Steam sterilizers should be descaled in accordance with the manufacturer’s instructions. • Repeated processing according to these instructions has minimal effect on Biomet reusable manual instruments unless otherwise noted. End of life for stainless steel or other metal surgical instruments is normally determined by wear and damage due to the intended surgical use and not to reprocessing. See also the Reusable Instrument Lifespan Manual 1219 for determining end of life by wear and damage due to use. • Polymers used in Biomet instrument sets can be sterilized using steam/ moist heat. Polymer materials have a limited useful life. If polymer surfaces turn “chalky,” show excessive surface damage (e.g. crazing or delamination), or if polymer devices show excessive distortion or are visibly warped, they should be replaced. Notify your Zimmer Biomet representative if polymer devices need to be replaced. • Most currently available polymers will not withstand conditions in washers/sterilizers that operate at temperatures equal to or greater than 141 °C / 285 °F, and use live-steam jets as cleaning features. Severe surface damage to polymer devices may occur under these conditions. • Stainless steel instruments may be treated with rust removal agents approved for surgical instruments if needed. • Titanium and titanium alloy devices are especially susceptible to discoloration from steam impurities and detergent residues which form multi-coloured surface layers of oxide deposits. Upon repeated sterilization, these oxide layers, while not harmful to the patient, may become dark and obscure graduation marks, item and lot numbers, and other stamped or etched information. Acidic, anti-corrosion agents may be used to remove this discoloration as needed.
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Use of hard water should be avoided. Softened tap water may be used for initial rinsing. Purified water should be used for final rinsing to eliminate mineral deposits on instruments.
CLEANING AND DISINFECTION (See also Instrument Assembly and Disassembly Manual 1258 or product-specific Assembly and Disassembly Manual, where applicable, available from your Zimmer Biomet sales representative or at http://labeling.zimmerbiomet.com). Note: for first use, remove and dispose of all packaging material before cleaning and sterilizing instruments. A. Point-of-Use Preparation for Reprocessing Remove excess body fluids and tissue from instruments with a disposable, nonshedding wipe. Place instruments in a basin of distilled water or in a tray covered with damp towels. Do not allow saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on instruments prior to cleaning. Note: Soaking in proteolytic enzyme solutions or other pre-cleaning solutions facilitates cleaning, especially in instruments with complex features and hard-toreach areas (e.g. cannulated and tubular designs, etc.). These enzymatic solutions, as well as enzymatic foam sprays, break down protein matter and prevent blood- and protein-based materials from drying on instruments. Manufacturer’s instructions for preparation and use of these solutions should be explicitly followed. For optimal results, instruments should be cleaned within 30 minutes of use or after removal from solution to minimize the potential for drying prior to cleaning. Used instruments must be transported to the central supply in closed or covered containers to prevent unnecessary contamination risk. Do not place soiled instruments back in the instrument case. B. Preparation before Cleaning Loosen and/or disassemble instruments with removable parts. Care should be exercised to avoid losing small screws and components. If a part is lost, notify your Zimmer Biomet representative when the instrument set is returned. Instruments with removable polymer sleeves must be disassembled for sterilization (e.g. acetabular reamer shaft with sleeve, side cutters, etc.). Symbols or specific instructions etched on instruments or instrument trays and cases should be strictly followed. See also Instrument Assembly and Disassembly Manual 1258 or product-specific Assembly and Disassembly Manual, where applicable, for disassembly instructions prior to cleaning/ sterilization. C. Preparation of Cleaning Agents Neutral pH, enzymatic, and alkaline cleaning agents with low foaming surfactants are recommended. Alkaline agents with pH ≤ 12 may be used in countries where required by law or local ordinance. Alkaline agents should be followed with a neutralizer and/ or thorough rinsing. Only agents with proven efficacy (FDA approved, VAH listed, or CE mark) should be used. As a wide variety of cleaning agents and disinfectants exists globally, Zimmer Biomet does not recommend any specific brand. Agents used during the validation of these processing instructions are as follows: 1. Enzymatic and Neutral Detergents: Steris®, Prolystica® 2X Concentrate Enzymatic Presoak and Cleaner and Prolystica® 2X Concentrate Neutral Detergent. 2. Alkaline Detergent and Neutralizer: neodisher® FA Alkaline Detergent and neodisher® Z Acid Neutralizer. All cleaning agents should be prepared at the use dilution and temperature recommended by the manufacturer. Softened tap water may be used to prepare cleaning agents. Use of recommended temperatures is important for optimal performance of cleaning agents. Dry powder cleaning agents should be completely dissolved prior to use to avoid staining or corrosion of instruments and to ensure correct concentration. Fresh cleaning solutions should be prepared when existing solutions become grossly contaminated (bloody and/ or turbid). Note: It is important to select enzymatic solutions intended for breakdown of blood, body fluids and tissues. Some enzymatic solutions are specifically intended for breaking down faecal matter or other organic contaminants and may not be suitable for use with instruments. D. Combination Manual/Automated Cleaning and Disinfection Instructions 1. Completely submerge the instruments, trays, cases and lids in an enzyme or alkaline (pH ≤12) solution and allow to soak and sonicate for 10 minutes at 40±5 kHz. If using enzymatic cleaning agents, use a soft nylon bristled brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hardto-clean areas. Lumens should be cleaned with a long, narrow, soft nylon bristled brush (i.e. pipe cleaner). Note: Use of a syringe or water jet will improve flushing of difficult-toreach areas and closely mated surfaces. 2. Remove instruments from the cleaning solution and rinse in purified water for a minimum of 1 minute. Thoroughly and aggressively flush lumens, blind holes and other difficult-to-reach areas. 3. Place instruments in a suitable washer/disinfector basket and process through a standard instrument washer/disinfector cleaning cycle. The minimum parameters in Tables 2 and 3 are essential for thorough cleaning and disinfection.
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Note: The washer/disinfector manufacturer’s instructions should be strictly adhered to. Use only cleaning agents recommended for the specific type of automated washer/ disinfector. A washer/disinfector with approved efficacy (e.g. CE mark, FDA clearance, and validation according to ISO 15883) should be used. Table 2. Typical U.S. Automated Washer/Disinfector Cycle for Surgical Instruments Step Description 1 2 minute prewash with cold tap water 2 20 second enzyme spray with hot tap water 3 1 minute enzyme soak 4 15 second cold tap water rinse (X2) 5 2 minute detergent wash with hot tap water (64-66 °C/146-150 °F) 6 15 second hot tap water rinse 7 2 minute thermal rinse (80-93 °C/176-200 °F) 8 10 second purified water rinse with optional lubricant (64‑66 °C/146-150 °F) 9 7 to 30 minute hot air dry (116 °C/240 °F) Table 3. Typical European Automated Washer/Disinfector Cycle for Surgical Instruments Step Description 1 5 min pre-rinse with cold tap water 2 10 min alkaline cleaning agent wash at 55 °C 3 2 min rinse with neutralizer 4 1 min rinse with cold tap water 5 Disinfection at 93 °C with hot purified water until A0 3000 is reached (approx. 10 min) 6 40 min hot air drying at 110 °C 4. Proceed to Inspection, Maintenance, Testing, and Lubrication. INSPECTION, MAINTENANCE, TESTING, AND LUBRICATION (See also Reusable Instrument Lifespan Manual 1219, available from your Zimmer Biomet sales representative or at http://labeling.zimmerbiomet.com) 1. Carefully inspect each device to ensure that all visible contamination or biological residues have been removed. If contamination is noted, repeat the cleaning and disinfection process. 2. Visually inspect for completeness, damage and/or excessive wear. Please see the Reusable Instrument Lifespan Manual 1219 for determining end of life by wear and damage due to use. Note: If damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your Zimmer Biomet representative for a replacement. 3. Check the action of moving parts (e.g. hinges, box-locks, connectors, sliding parts, etc.) to ensure smooth operation throughout the intended range of motion. 4. If necessary, hinged, rotating, or articulating instruments can be lubricated with an instrument product (e.g. instrument milk or equivalent lubricant) specifically designed for compatibility with steam sterilization. Note: These lubrication instructions are not applicable to air-powered or electrical instruments. These devices have different requirements and should be lubricated according to the manufacturer’s instructions. Note: Lubricants not specifically designed for compatibility with steam sterilization should not be used because they: 1) may coat microorganisms; 2) may prevent direct contact of the surface with steam; 3) are difficult to remove. 5. Check instruments with long slender features (particularly rotating instruments) for distortion. 6. Where instruments form part of a larger assembly, check that the devices assemble readily with mating components. REPROCESSABLE INSTRUMENTS STERILE PACKAGING – ONLY APPLICABLE FOR INSTRUMENTS DELIVERED IN NON STERILE CONFIGURATION A. Packaging Individual Instruments • Devices provided non-sterile are indicated by the symbol on the label. • Single devices should be packaged in a medical grade sterilization pouch or wrap which conforms to the recommended specifications for steam sterilization provided in Table 4. Ensure that the pouch or wrap is large enough to contain the device without stressing the seals or tearing the pouch or wrap. • The sterilization wrap used should be FDA cleared and comply with European regulations.
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Standard medical grade, steam sterilization wrap may be used to package individual instruments. The package should be prepared using the AAMI double wrap or equivalent method.
Table 4. Recommended Steam Sterilization Parameters Cycle Type
Temperature
Note: If sterilization wraps are used, they must be free of detergent residues. Reusable wraps are not recommended.
U.S. Prevacuum U.K. Prevacuum Prevacuum1,2
132 °C / 270 °F 134 °C / 273 °F 134 °C / 273 °F
B. Packaging Instrument Sets in Rigid Trays and Cases with Lids • Safety Precaution: The total weight of a wrapped instrument tray or case should not exceed 11.4kg/25lb. Instrument cases may be placed in an approved sterilization container (e.g. Aesculap) with gasketed lids at the user’s discretion. The total weight of the instrument set, case, and sterilization container, must not exceed 11.4kg/25lb (other local limits below 25lb may apply). • Trays and cases with lids may be wrapped in standard medical grade, steam sterilization wrap using the AAMI double wrap method or equivalent. • The sterilization wrap used should be FDA cleared and comply with European regulations. • Trays and cases with lids may also be placed in an approved sterilization container with gasketed lid for sterilization. • Follow the sterilization container manufacturer’s instructions for inserting and replacing sterilization filters in sterilization containers. • Areas designated for specific devices shall contain only devices specifically intended for these areas. • All devices must be arranged to ensure steam penetration to all instrument surfaces. Instruments should not be stacked or placed in close contact. • Any device capable of disassembly must be disassembled prior to placement in the case. C. Instrument trays and cases with defined, preconfigured layouts • Areas designated for specific devices shall contain only devices specifically intended for these areas. • Optional Biomet instruments should not be added to a preconfigured instrument tray or case unless a dedicated universal space or compartment has been included in the design and the guidelines described below for trays and cases without defined layouts or universal spaces can be applied. STERILIZATION • Flash (immediate-use) steam sterilization is not recommended. • Ethylene oxide or gas plasma sterilization methods should not be used unless package inserts for the applicable product specifically provide instructions for sterilization using these methods. • The hospital is responsible for in-house procedures for the reassembly, inspection, and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. Provisions for protecting any sharp or potentially dangerous areas of the instruments should also be recommended by the hospital. • Steam sterilizer manufacturer recommendations should always be followed. When steam sterilizing multiple instrument sets in one sterilization cycle, ensure that the manufacturer’s maximum load is not exceeded. • Instrument sets should be properly prepared and packaged in trays and/ or cases that will allow steam to penetrate and make direct contract with all surfaces. • See Table 4 for recommended minimum steam sterilization parameters that have been validated to provide a 10-6 sterility assurance level (SAL). Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the table. Note: The sterilizer manufacturer’s instructions for operation and load configuration should be followed explicitly.
Exposure Time 4 minutes 3 minutes 18 minutes
Minimum Dry Time3
Minimum Cool Time4
30 minutes
30 minutes
Disinfection/steam sterilization parameters recommended by the World Health Organization (WHO) for reprocessing instruments where there is concern regarding TSE/CJD contamination. 2 This cycle is not to be used for the inactivation of prions. 3 Drying times vary according to load size and should be increased for larger loads. 4 Cooling times vary according to the type of sterilizer used, device design, temperature and humidity of ambient environment, and type of packaging used. Cooling process should comply with ANSI/AAMI ST79. 1
STORAGE, HANDLING AND SHELF LIFE • Sterile, packaged instruments should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, vermin, sunlight and temperature/humidity extremes. • Care must be exercised when handling wrapped cases or individual instruments to prevent damage to the sterile barrier. • The health care facility should establish a shelf life for sterilized instrumentation based upon the type of sterile wrap or rigid container used and the recommendations of the sterile wrap or rigid container manufacturer. • Sterile instrument packages should be carefully examined prior to opening to ensure that package integrity has not been compromised. Note: Maintenance of sterile package integrity is generally eventrelated. If a sterile wrap is torn, perforated, shows any evidence of tampering or has been exposed to moisture, the instrument set must be cleaned, repackaged and sterilized. Note: If there is any evidence that the lid seal or filters on a sterilization container have been opened or compromised, the sterile filters must be replaced and the instrument set resterilized. •
Non-sterile provided instruments are to be stored in the appropriate packaging that protects the instruments from damage or in an appropriate instrument tray. Instruments must be examined for possible damage before use. Protective caps or other protective elements must be removed before cleaning.
DISPOSAL INFORMATION After use, an instrument is a potential biohazard, since it may be contaminated with blood or other body fluids, bone or other tissue. Handle and dispose of this product in accordance with accepted medical practice and with applicable local, state and national laws and regulations. In the event of an alleged product failure it is important to have the instrumentation returned to Zimmer Biomet for investigation. Any sharp objects should be disposed of immediately after use into a sharps container conforming to EN ISO 23907-1 or equivalent following the requirements in Directive 2010/32/EU or equivalent national laws. The sharp object must not be bent, broken or resheathed prior to disposal. REPORTING PROBLEMS Healthcare professionals, users and patients should report any suspected serious incident related to the device to the manufacturer at www.zimmerbiomet.com and to the competent authority of the member state in which the serious incident has occurred. CAUTION: Federal Law (USA) restricts this device to sale by, or on the order of a physician. All trademarks herein are the property of Zimmer Biomet or its affiliates unless otherwise indicated. Steris® and Prolystica® are registered trademarks of Steris Corporation. Neodisher® is a registered trademark of Chemische Fabrik Dr. Weigert GmbH. CE Mark on the package insert (IFU) is not valid unless there is a CE Mark on the product (description) label.
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